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Active (not recruiting) NCT01382082

Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy

Conditions: Breast Cancer Lymphoma

Sponsor: University of Rochester NCORP Research Base

trial.available_in: БГ
Overview
Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties. This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.
Who can participate
Inclusion Criteria: Subjects Receiving Chemotherapy: * Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade\* lymphoma (\*defined by the treating physician) * Be scheduled to begin a course of chemotherapy * Oral chemotherapy is acceptable * Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible). * Be chemotherapy naïve * Life expectancy greater than 10 months * Be able to speak and read English * Give written informed consent Inclusion Criteria, Controls: * Must be the same gender as the subject receiving chemotherapy * Must be within 5 years of the age of the subject receiving chemotherapy * Life expectancy greater than 10 months * Be able to speak and read English * Give written informed consent * Must be willing to participate in the study for the entire period Inclusion Criteria, Long-Term Followup Study: * Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3. Exclusion Criteria: Subjects Receiving Chemotherapy: * Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness * Must not be diagnosed with a neurodegenerative disease * Must not have primary central nervous system (CNS) disease * Must not have received chemotherapy in the past * Must not be scheduled to receive concurrent radiation treatment * Must not have metastatic disease (subjects with breast cancer) * Must not be pregnant * Must not be colorblind Exclusion Criteria, Controls: * Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness * Must not be diagnosed with a neurodegenerative disease * Must not have primary CNS disease * Must not have been diagnosed with cancer or previously have received chemotherapy * Must not be pregnant or plan on becoming pregnant during the study period * Must not be colorblind Exclusion Criteria, Long-Term Followup Study: * Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing. * Must not be colorblind
Locations 29
United States (29)
Columbus NCORP
Columbus , Ohio
Columbus
Columbus , Ohio
Dayton Community Oncology Program
Dayton , Ohio
Dayton
Dayton , Ohio
Heartland
Decatur , Illinois
Hem Onc CNY
East Syracuse , New York
Cancer Research Consortium of West Michigan
Grand Rapids , Michigan
CRCWM
Grand Rapids , Michigan
NCORP of the Carolinas
Greenville , South Carolina
CCOP - Nevada Cancer Research Foundation
Las Vegas , Nevada
Nevada
Las Vegas , Nevada
Wisconsin NCORP
Marshfield , Wisconsin
Aurora NCORP
Milwaukee , Wisconsin
Metro Minnesota NCORP
Minneapolis , Minnesota
Gulf South MU-NCORP
New Orleans , Louisiana
Delaware/Christiana Care NCORP
Newark , Delaware
Delaware/Christiana Care NCORP (CHRISTIANA)
Newark , Delaware
Pacific Cancer Research Consortium Ncorp
Portland , Oregon
PCRC
Portland , Oregon
Kansas City Clinical Oncology Program
Prairie Village , Kansas
Kansas City
Rochester , New York
University of Rochester Cancer Center
Rochester , New York
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park , Minnesota
Northwest (Virginia Mason)
Seattle , Washington
Upstate Carolina
Spartanburg , South Carolina
Wichita NCORP
Wichita , Kansas
Wichita
Wichita , Kansas
Novant Health Cancer Institute - Kernersville
Winston-Salem , North Carolina
Southeast Clinical Oncology Research Program
Winston-Salem , North Carolina
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
21 Years
Healthy volunteers
No
Start date
14.07.2011
Completion date
31.12.2026
Registry ID
NCT01382082
Source
clinicaltrials.gov
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